DeepWell's Biofeedback SDK Receives FDA Clearance for Stress Reduction and Blood Pressure Management

The US Food and Drug Administration has granted DeepWell clearance to utilize its biofeedback SDK as a therapeutic tool for mitigating stress and high blood pressure. This development enables DeepWell to make the SDK available to other companies, with the ultimate goal of 'accelerating the commercialization of video games and other immersive media as FDA-cleared digital therapeutics.' Notably, any media incorporating DeepWell technology can be accessed without a prescription. The SDK is designed to provide 'biostimulation in interactive media that activates the user's vagus nerve while greatly increasing patient engagement, reducing sympathetic nervous system activation, and releasing dopamine for coping that improves resilience to reduce stress and hypertension.' According to a company spokesperson, the SDK can be integrated in three primary ways, including incorporating breathing mechanics directly into gameplay, offering it as an adjunct to media, or adding it to a platform of organized content. For instance, a sports game could utilize a breathing mechanic to improve player accuracy, or a 'Mental health' tab on a streaming platform could recommend games or media with the breathing mechanic enabled. While the exact differences between this technology and existing mental health-focused apps are unclear, DeepWell co-founder Dr. Samuel Browd noted that only 20 out of 350,000 digital wellness products have received FDA clearance, including just five for mental health and one SDK. The company's co-founder and chairman, Ryan Douglas, emphasized the potential for the technology to be used in future digital treatments for various conditions, including pain, PTSD, and sleep disorders.